Respiratory system and method that monitors medication flow

ABSTRACT

A respiratory system and method comprise a tracker module adaptable to be secured to a variety of inhalers, the tracker module sensing activation of the medication canister of the inhaler for delivery of medication to a user. The tracker module also senses the rate of inhalation air flow of the user when inhaling medication for determination of proper inhaler use. Upstream and downstream sensors provide flow information to determine quality of the inhalation. A flow sensor is an integral part of the tracking module and can be used on multiple inhalers. Other sensors are provided that monitor user presence at the inhaler, user technique in using the inhaler, and the attitude of the inhaler when it was used. Low power devices are used to conserve battery power. A spirometer provides user lung function data.

RELATED APPLICATIONS

This application is a continuation-in-part of U.S. application Ser. No.15/956,586, filed Apr. 18, 2018, which is a division of U.S. applicationSer. No. 14/518,529, filed Oct. 20, 2014, now U.S. Pat. No. 10,019,555,which claimed the benefit of U.S. Provisional Application No.61/893,210, filed Oct. 19, 2013, and which further claimed the benefitof U.S. Provisional Application No. 62/055,801, filed Sep. 26, 2014; thepresent application also claiming the benefit of U.S. ProvisionalApplication No. 62/724,020, filed Aug. 28, 2018, and the benefit of U.S.Provisional Application No. 62/797,833, filed Jan. 28, 2019, all ofwhich are incorporated herein by reference.

FIELD OF THE INVENTION

The present invention generally relates to respiratory devices includinginhalers and spirometers, and more particularly to a system and methodof monitoring the administration of medication from the respiratorydevice.

BACKGROUND

Asthma is a chronic disease of the airways that transport air to andfrom the lungs. In a person with asthma, the inside walls of theairways, known as bronchial tubes, become swollen or inflamed. Thisswelling or inflammation makes the airways extremely sensitive toirritations and increases their susceptibility to an allergic reaction.This can make breathing difficult and can trigger coughing, wheezing,and shortness of breath. The muscles that wrap around the airways alsocan tighten, making breathing even harder. When that happens, it isoften called an asthma flare-up, asthma episode, or an asthma attack.

Other diseases are similar to asthma. Chronic obstructive pulmonarydisease, often referred to as COPD, is an umbrella term for chronicbronchitis and emphysema. Chronic bronchitis inflames the bronchialtubes while emphysema is characterized by loss of elasticity in thelungs. Asthma and COPD may be treated by the use of inhaled medicationwhere other diseases are treated differently.

Certain medications are used to relieve symptoms of asthma and COPD.They work by relaxing the muscles of the airways into the lungs, whichmakes it easier to breathe. When an asthmatic has an asthma attack, aninhaler gets the medicine straight to the lungs, so it can quickly relaxthe muscles surrounding the airways. The airways can then open morewidely, making it easier to breathe again. Within just a few minutes,breathing becomes easier.

Inhalers are commonly used to provide oral or intra-nasal medication topatients. They can be used for relief on an as-needed basis, as well asfor application of a prescribed course of treatment. The user segment ofparticular significance to the present invention is the large populationfor whom there is a prescribed course of treatment using an inhaler. Theeffectiveness of the inhaler is dependent on the user's adherence to thetreatment regimen and this has traditionally been a problem area. Thisis also referred to as a user's “compliance” with the treatment regimen.There are approximately 26 million persons in the United States alonewho suffer from chronic asthma, and whose poor adherence rate greatlycontributes to an estimated $300 billion in preventable indirect anddirect medical costs annually. On average, children and adults adhere totheir prescription schedule with less than a 50% success rate (i.e.,they do not administer their medication more than 50% of the timeprescribed). One easily quantifiable direct cost of poor adherence isthe $18 billion spent on Emergency Room (ER) visits where poor inhalermedication adherence is cited as the number one cause for ER visits.

A higher degree of adherence to the course of treatment would improveresults in many cases, and in those cases where the treatment isineffective the physician and patient can move on to a differentsolution rather than continuing with a course of treatment thinking thatit would be effective if followed.

The medical field has long recognized the problem of a patient visitinga physician and having a very imprecise recollection of how often theinhaler has been used. Solutions proposed to solve this problem includethose described in U.S. Pat. No. 6,958,691 to Anderson, et al., U.S.Pat. No. 6,202,642 to McKinnon, U.S. Pat. No. 5,363,842 to Mishelevich,Published U.S. Patent Application No. 2011/0253139 of Guthrie, et al,Published U.S. Patent Application No. 2009/0194104 of Van Sickle, andpublished international patent application WO 2014/004437 of Engelhard,et al. These prior devices claim to monitor inhaler usage and track theuser's adherence to a treatment regimen. However, they are often bulky,or require customized inhalers (i.e., cannot be easily fitted to andoperated with any inhaler already in use). Some also require specialpurpose hardware to collect data and forward it to the physician.

An additional problem, exacerbated by poor adherence to a course oftreatment is the difficulty in obtaining sufficient data regardingchanges in lung function, and in making timely adjustments of theprescribed treatment regimen in accordance with updated lung function.

A hand-held or single-dose inhaler is often a passive device thatprovides no information regarding the medication actually delivered. Insome cases, patients who use the inhaler are not clear as to whetherthey actually received a dose. Multiple efforts have been made in thepast to assist a patient with the correct use of an inhaler. Manypatients use inhalers incorrectly which results in poor inhalationtechniques and a lack of efficacy of the medication. It has been notedthat in one study, up to 80% of the patients use an incorrect inhalertechnique. Spacer tubes, which typically comprise a valved holdingchamber located between the mouthpiece of an inhaler and the patient,have been found to be helpful with some patients; however, many patientsdo not utilize them because of their bulk and the patient's desire notto attract attention when using an inhaler. A counter that is built intoan inhaler is also a useful device; however, a counter does notnecessarily indicate that the patient received a dose. The counter onlyindicates that a dose was delivered by the inhaler but does not indicatethat the patient received it.

People who have asthma or chronic obstructive pulmonary disease (COPD)or other breathing disorders often use devices either called ahydrofluoroalkane inhaler (HFA inhaler, also referred to as a metereddose inhaler or MDI), or a dry powder inhaler (DPI). An HFA inhaler is ahandheld device that delivers a specific amount of medication in aerosolform, rather than as a pill or capsule. The HFA inhaler consists of apressurized canister inside a plastic case (inhaler body), with amouthpiece attached. With an HFA inhaler, the user presses on thecanister while inhaling the COPD medication directly into his or herlungs. The portability of these inhalers makes them easy to use.

A metered dose inhaler (MDI) is a small device that delivers a measureddose of medicine in a fine spray (aerosol) at the mouthpiece of theinhaler. MDIs use a chemical propellant to produce the spray and thepropellant carries the measured amount (dose) of medicine. If the user'smouth is correctly located on the mouthpiece of the inhaler, the spraywill be delivered into the user's mouth. However, to be effective, thespray must be drawn into the user's lungs. The “spray” from an inhaleris sometimes referred to as a puff.

DPIs are also handheld devices. A DPI delivers medication to the lungsas the user inhales through the inhaler. It does not contain propellantsor other ingredients; it contains only the medication. DPIs arebreathe-activated; i.e., it is the breathing in deeply and fast thatgives the user the right dose of medicine from the DPI. The user's lungstrength at inhaling alone is what draws the medication into his or herlungs, as opposed to the MDI that has a propellant for delivery of themedication. The DPI requires a minimum inspiratory flow rate from apatient to work effectively, and the minimum flow rate required toadminister effectively varies by DPI medication.

If a user's inhaler technique is not consistent with the mechanics ofdelivery of the spray by the inhaler, the user may not get much of themedicine into his or her lungs and relief may not occur. Problems oftenarise with the MDIs where the user must coordinate pressing down on theinhaler to get the spray at the same time as the user breathes it indeeply enough. If the user presses before breathing in, most of thespray ends up on the back of the user's throat rather than in the user'slungs. If the user presses too late after breathing in, most of the doseends up in the mouth where it will promptly get breathed out again.There are various other technique deficiencies that can cause the above.

There are economic advantages of improving the user's inhalationtechnique. Poor inhaler technique can lead to worse asthma control andpossibly a prescription for higher doses and different medications thatmay not be necessary.

At this time no technique is known for measuring the amount of sprayfrom an inhaler that actually reaches the user's lungs. Similarly, notechnique is known for measuring the amount of spray from an inhalerthat actually passes through a user's airways.

New developments have been made in detecting and reporting the actuationof an inhaler canister of an MDI. Cohero Health, Inc., New York, N.Y.has devices that allow the electronic tracking of MDI actuations andrecording of those actuations with a connected app and a connecteddatabase (often referred to as an electronic metered dose inhaler or“eMDI”). However, these eMDI devices are still susceptible to actuationwithout effective user inhalation of the medication when a user does nothave a good inhaler technique. A need has been identified for a systemand method that provides more confidence that the user correctly inhaledthe medication when an actuation of the inhaler is detected andrecorded. Another use for such a system and method is to detectineffective or “poor” inhalation as a result of incorrect inhalertechnique.

Based on the above discussion, there is a need to monitor the use of aninhaler by a user to determine if the user's inhaler technique issufficient for the user to have received a full dose of medication.Further, a need has been identified to sense and correlate multiplefactors to determine if a patient has effectively used an inhaler tohave breathed in a dose of medication deeply enough to reach the lungs.

There is also an identified need for the recordation of data resultingfrom a user's actuation of an inhaler and breathing the spray forsimultaneous or later review by a healthcare practitioner to monitor theuser's technique and consult with the user later should the user'stechnique be found to be deficient.

Those of skill in the art have also identified a need for a system andmethod that is configured to gage or grade the quality of a user'sinhalation.

There is a further need for a system with which real-time lung functiondata can be obtained, correlated with actual inhaler usage, the patienttreatment regimen reassessed, and the patient advised of the updatedtreatment regimen without having to visit a physician.

There is a need, then for a system and method that can be used with themajority of inhaler devices already in use and is likely compatible withthose developed in the future and is simple in both design andoperation, thereby encouraging more widespread use.

There is a still further need for a system that can make use ofrespiratory data of a larger number of people to conductpopulation-level analysis. For example, identifying sub-populations thatrespond similarly to medications.

The present invention fulfills these needs and others.

SUMMARY OF THE INVENTION

Briefly and in general terms there is provided a system and a method tomonitor inhaler use by a user. Proper use of the inhaler can beconfirmed, and improper use can be detected. Data representing a qualityof inhalation is provided that can be used by a health carepractitioner.

According to the present invention, there is provided a respiratorydevice monitoring system for monitoring the use of an inhaler, theinhaler having an inhaler body containing an inhaler medication that isactivated to provide a medication dose, an internal inhaled-air passage,and a mouthpiece, the inhaler configured so that both the inhalermedication and the inhaled-air passage are connected to the mouthpieceat a point of convergence whereby a user of the inhaler who inhalesthrough the mouthpiece will inhale both the dose of medication and airthrough the inhaled-air passage, the monitoring system comprising atracking module comprising a flexible shell configured to be mountedaround the body of the inhaler, the flexible shell including an inhalermedication dose sensor configured to detect activation of the inhalermedication to provide a dose of medication through the mouthpiece of theinhaler, the medication dose sensor providing dose data upon sensingthat the inhaler medication has been activated, the flexible shell alsohaving a tracking module processor to which are connected a trackingmodule non-transient memory, and a tracking module communicationscomponent, the flexible shell also including a tracking module battery,wherein the battery is configured and connected to provide electricalpower to the processor, the memory, and the communications component;wherein the tracking module processor is programmed to receive dose dataand store the received dose data in the tracking module memory with anassociated time/date stamp; the tracking module further comprising anair flow sensor located at the inhaled-air passage configured to sense aphysical parameter of air drawn through the inhaled-air passage to themouthpiece and to output inhaled-air data representative of that sensedphysical air parameter to the processor, wherein the processor isprogrammed to receive the inhaled-air data and to store the inhaled-airdata in the non-transient memory with an associated time/date stamp, andan application stored in a local device in electrical communication withthe communications component, the application configured to program thelocal device to communicate with the tracking module processor totransmit stored dose data and associated time stamps and inhaled-airdata and associated time/date stamps to the local device, wherein theapplication programs the local device to process the received dose dataand the inhaled-air data with respective time stamps together.

In another aspect in accordance with the invention, the air flow sensoris located in the inhaled-air passage upstream of the point ofconvergence of the inhaler medication and the inhaled air passage, theair flow sensor comprising a pressure sensor configured to provideupstream pressure data to the tracking module processor for storage inthe tracking module memory with associated time/date stamps. Further,the application programs the local device to receive upstream pressuredata and dose data from the tracking module, and to compare length timeand pressure of the upstream pressure of the inhaled air with the timeof the dose data to provide inhaler technique data based on thecomparison.

In another aspect, the air flow sensor is located in the inhaled-airpassage downstream of the point of convergence of the inhaler medicationand the inhaled air passage, the air flow sensor comprising a pressuresensor configured to provide downstream pressure data to the trackingmodule processor for storage in the tracking module memory withassociated time/date stamps. Further, the application programs the localdevice to receive downstream pressure data and dose data from thetracking module; and to compare length time and pressure of thedownstream pressure of the inhaled air with the time of the dose data toprovide inhaler technique data based on the comparison.

In yet another feature of the invention, the air flow sensor comprises afirst air flow sensor located in the inhaled-air passage upstream of thepoint of convergence of the inhaler medication and the inhaled airpassage, and a second air flow sensor located in the inhaled-air passagedownstream of the point of convergence of the inhaler medication and theinhaled air passage. Wherein the first and second air flow sensorscomprise first and second pressure sensors respectively and the firstpressure sensor provides upstream pressure data to the tracking moduleprocessor for storage in the tracking module memory with associatedtime/date stamps, and the second pressure sensor provides downstreampressure data to the tracking module processor for storage in thetracking module memory with associated time/date stamps. Also, theapplication programs the local device to receive upstream pressure dataand downstream pressure data and dose data from the tracking module, andto compare lengths of time and pressure of the upstream and downstreampressures of the inhaled air with the time of the dose data to provideinhaler technique data based on the comparison.

In an additional aspect, the tracking module further comprises abiometric sensor configured to receive biometric data of a possibleuser. Wherein the tracking module memory includes identification data ofthe inhaler to which the tracking module is mounted, wherein thetracking module processor is further programmed to receive biometricdata from the biometric sensor, and transmit the received biometric datato the local device, and wherein the application running on the localdevice programs the local device to compare the received biometric datafrom the tracking module processor and compare the received biometricdata to authorized user data, and depending on the comparison, indicatethat the received biometric data matches an approved user of theinhaler.

In yet an additional feature, the application programs the local deviceto receive inhaled air data and dose data from the tracking module for aparticular inhalation, process the received inhaled air data to provideflow rate data, and compare the flow rate of the inhalation to the dosedata to determine a quality of inhalation. The local device includes adisplay wherein the application programs the local device to display thequality of inhalation on the display.

Further features include the tracking module further comprises an airflow control device having an orifice of a known size, the air flowcontrol device configured to block ambient air from flowing into theinhaled-air passage of the inhaler except through the orifice in the airflow control device, wherein the application programs the local deviceto determine the flow rate based on the time of inhalation and the knownsize of the orifice. Wherein the air flow sensor comprises a pressuresensor located in the inhaled-air passage upstream of the convergencepoint, and wherein the local device is programmed to determine the flowrate based on dose data, pressure data, and the known size of theorifice.

Aspects also include the tracking module including an accelerometer thatprovides acceleration data, location data, and three-dimensionalmovements and orientation of the inhaler data, wherein the trackingmodule further comprises a user proximity sensor that senses theproximity of a user to the inhaler and provides user proximity data, theapplication programs the local device to receive dose data, air-flowdata, environmental data, and medication use data; and the applicationprograms the local device to determine a quality of inhalation based ona comparison of the dose data, air-flow data, environmental data, andmedication use data. In one case, environmental data includes at leastone of temperature, humidity, allergens, pollution, and airparticulates, and medication use data includes at least one of asthmatreatment pills, injector pen use, and other medication use. The localdevice is programmed to provide coaching to a user to improve inhalationtechnique based on the quality of inhalation determined from the datacomparison.

Another aspect is that the application programs the local device tooperate in a training mode where dose data and air-flow data receivedfrom the tracking module are compared to provide advice to a user tochange inhalation technique.

A further feature of the invention is that the tracking module comprisesan accelerometer fixedly attached to the tracking module and connectedwith the tracking module processor, the accelerometer configured toprovide data concerning shaking movement of the inhaler body to whichthe tracking module is mounted, wherein the tracking module processor isprogrammed to receive and store dose data and the accelerometer shakingdata in the tracking module memory.

In yet another feature, the tracking module further comprises azero-power vibration sensor connected to the tracking module processor,the vibration sensor providing a vibration signal upon sensing vibrationof the tracking module, wherein the tracking module is programmed toremain in a low-power consumption sleep mode until a vibration signal isreceived at which time the tracking module enters an operational mode.

Another feature is that the tracking module and the air flow sensorattached thereto are configured to be mounted temporarily to an inhalerand are thereby reusable with multiple inhalers.

In a method of monitoring the use of an inhaler, the inhaler having aninhaler body containing an inhaler medication that is activated toprovide a medication dose, an internal inhaled-air passage, and amouthpiece, the inhaler configured so that both the inhaler medicationand the inhaled-air passage are connected to the mouthpiece at a pointof convergence whereby a user of the inhaler who inhales through themouthpiece will inhale both the dose of medication and air through theinhaled-air passage, the method comprises sensing the administration ofa dose of inhaler medication and storing dose data representative of thesensed dose in a tracking module memory with a date/time stamp, thetracking module having a flexible shell that is mounted around the bodyof the inhaler, restricting the flow of air into the inhaled-air passageof the inhaler through only an orifice of a known size, measuringpressure of air flowing through the inhaled-air passage during aninhalation, storing in the tracking module memory the sensed pressure ofair flow with an associated time/date stamp, and programming a localdevice that is in electrical communication with the tracking module toreceive the stored dose data and associated time stamps and inhaled-airdata and associated time/date stamps, and processing the received dosedata and the inhaled-air data with respective time stamps together, andcalculating flow rate of inhalation based on the measured pressure ofair flowing through the inhaled-air passage during a time of inhalation.

The features and advantages of the invention will be more readilyunderstood from the following detailed description that should be readin conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more clearly understood from the followingdetailed description in conjunction with the accompanying drawings,wherein:

FIG. 1 is a block diagram of an adherence tracking system according toan embodiment of the present invention in which respiratory devices;i.e., in this case a controller inhaler, a rescue inhaler, and aspirometer, are used with the respiratory system of a patient. Thefigure also shows a tracking module connected with the respiratorydevices, a local station, a communications network, and a server thatcontrols a memory and permits access by a physician system;

FIG. 2 is a perspective view of one example of a tracking moduleaccording to the present invention shown mounted to an MDI, with thetracking module comprising a shell in contact with the inhaler and a capin contact with the medication canister;

FIGS. 3A, 3B, and 3C are perspective views of the tracking module ofFIG. 2 mounted on an inhaler, and showing the process of removing amedication canister from the inhaler;

FIGS. 4A and 4B show different perspective views of the tracking moduleof FIGS. 2 and 3A-3C with FIG. 4A showing a rear view of the uninstalledtracking module in which a sync button can be seen as well as a dosedetector sensor, and FIG. 4B showing a front view of the uninstalledtracking module in which the battery and electronics compartment can beseen;

FIGS. 5A, 5B, and 5C show a tracking module in accordance with aspectsof the invention mounted to a dry powder inhaler (DPI) with FIG. 5Ashowing the tracking module mounted to the DPI, FIG. 5B showing an endview of the tracking module of FIG. 5A uninstalled on a DPI, and FIG. 5Cshowing a top perspective view of the uninstalled tracking module ofFIG. 5A;

FIG. 6 shows an initial sign-on or register screen in an adherencemonitoring application program, or “app” in accordance with aspects ofthe invention;

FIG. 7 shows a registration screen of the app with an image of aHeroTracker® tracking module to automatically track inhaler medicationutilization;

FIG. 8 shows a symptoms and triggers tracking screen of the app with afull scroll down user interface to track and manage asthma environmentaltriggers;

FIG. 9 shows an app home screen in accordance with aspects of theinvention with a scroll down user interface for dynamic alerting anddisease management;

FIG. 10 is also an app home screen containing a summary of currentenvironmental conditions, predicted environmental conditions and risk,and an adherence percentage;

FIG. 11 is a partial cross-section view of a typical MDI in which acanister of medication/propellant has been mounted for actuation in aninhaler body, and further showing an upstream air flow sensor mounted inthe inhaled-air passage between the canister and the body of the inhalersuch that the flow of air through the inhaled-air passage when a userinhales a dose can be measured and data produced;

FIG. 12 is a perspective view of an embodiment of a HeroTracker® trackermodule used for detecting inhaler use, collecting data, and transmittingthat data wirelessly, the module shown having a cavity in which an MDImay be placed, the module also shown having a cap configured to press ona medication canister for actuation of the canister;

FIG. 13 is a top view of the tracker module of FIG. 12 showing theinhaler dose detector sensor located in the cap for use in detecting theactuation of a canister for detecting administration of a medicationdose;

FIG. 14 is a side perspective view of the tracker module of FIGS. 12 and13 mounted to an inhaler and showing the dose detector at the top incontact with the medication canister of the inhaler for detectingactuation of the canister to administer a medication dose to a user;

FIG. 15 is a perspective view of the embodiment of a tracking moduleshown in FIGS. 12, 13, and 14 installed over an MDI and configured inaccordance with aspects of the invention, the tracking module shown asincluding a user proximity sensor, an accelerometer, and a dosedetector;

FIG. 16 is a partial cross-sectional view of part of the embodiment ofFIG. 15 showing a dose detector of a tracker module comprising a switchand a protrusion to connect with the top of the medication canistermounted in an inhaler in accordance with aspects of the invention todetect actuation of the canister, the protrusion in this embodimenthaving an extended portion below the detector switch that is configuredto position a flow sensor into the air inhalation passage locatedbetween the canister and the inner surface of the inhaler body so thatair movement during inhalation can be detected and measured;

FIG. 17 is a perspective view of an inhaler in which a capacitive touchsensor has been mounted to the mouthpiece of the inhaler to sense auser's contact with the inhaler mouthpiece, and amicro-electromechanical system (MEMS) flow sensor has been mountedinside the mouthpiece to sense the flow of medicine through themouthpiece into the patient's mouth;

FIG. 18 is a diagram of an inhaler having an air flow control device inthe form of a cylinder having a closed end with an arc-shaped orifice ofa known size placed over the top end of the inhaler and installedcanister of medication;

FIG. 19 is a top view of the installed air flow control device of FIG.18;

FIG. 20 is a closer view of the air flow control device of FIG. 18having a circular orifice;

FIG. 21 is an air flow control device integrated into a tracking modulealso showing a ridge in the air control cylinder for mating with a slotformed in an inhaler shell to place a pressure sensor mounted at theinside surface of an inhaler directly under the orifice of known sizeshown in FIG. 21 so that more accurate flow sensing can occur;

FIG. 22 is a block diagram of an embodiment of a tracking module inaccordance with aspects of the invention showing sensors to monitor useof the inhaler, a processor and memory for executing a program orprograms and collecting and storing use data, and a communicationscomponent for transmitting data from the tracking module mounted to theinhaler to another location or locations such as to a remote server anddatabase (not shown);

FIG. 23 shows an inhaler to which a tracking module in accordance withaspects of the invention has been mounted, the tracking module of thisembodiment having an integrated spacer tube in which is located a flowsensor that is electrically connected with the processor of the trackermodule;

FIG. 24 is another embodiment of a tracker module having an integratedspacer tube that attaches around the mouthpiece and body of an MDI, thespacer tube having a flow sensor in the tube to sense flow of inhalermedication, the flow sensor being electrically connected to the trackermodule's processor as in the embodiment of FIG. 23;

FIG. 25 shows a block diagram of electronics of an embodiment of atracker module in accordance with aspects of the invention in which anIntel 8052 processor is shown along with inputs and outputs; and

FIG. 26 is a block diagram showing both mechanical and electricalcomponents of a tracker module in accordance with aspects of theinvention, also showing communications from the module to remote devicesfor transmitting data from the tracker to a remote memory or memoriesfor storage and for reference later.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring now in more detail to the exemplary drawings for purposes ofillustrating embodiments of the invention, wherein like referencenumerals designate corresponding or like elements among the severalviews, there is shown in FIG. 1 a monitor system 23 for a respiratorydevice in accordance with one embodiment is very broadly illustrated inFIG. 1. A tracking module 10 monitors operation of an inhaler 20 andreports by wired or wireless communication link to a local station 30with processing and communication capabilities. In the description thatfollows, the station 30 is a smart device such as a smartphone executingan application or “app” 46. although this is by way of example only. Thelocal station 30 may alternatively be a tablet, personal computer, orsome other device carried by the user. In a less preferred but viableimplementation the local station 30 may be a desktop computer or otherfixed processing system. The local station 30 processes the receivedsignals for transmission via a wired or wireless network 40 to a server50. The local station 30 may additionally process the data and provideanalysis results or reports to the user such as on a display of thelocal station, but in another embodiment of the invention it iscontemplated that the primary data processing location is at the server50. The server may be remotely located from the local station or inanother embodiment, may be nearby.

In the embodiment of FIG. 1, other data inputs are received.Environmental conditions, such as temperature and humidity, are receivedas well as irritant inputs. These include allergens, pollution, andparticulates. Additionally, a flow meter input is provided which is abasic type of lung function measurement. Finally, the user's medicationsare input. In one embodiment, this involves connecting with all wirelessmedications or medication packages, such wireless pill containers andinjector pens.

One or more databases are stored in a memory 52 with the server.Analysis results can then be accessed by a healthcare professional (forexample, a physician, nurse, or healthcare researcher) or other thirdparty from a remote terminal 60. The healthcare professional can makeuse not only of a specific patient's data from a database but alsorespiratory data of a larger number of people from another database toconduct population-level analysis. This may allow identification ofsub-populations that respond similarly to medications, for example,identifying trends not known before, such as children aged 10-15responding much better to medicine A than medicine B.

According to an embodiment of the invention, a monitoring server, mostlikely the server 50, forwards specific medical information to theElectronic Medical Records (EMR) system of the physician, including lungfunction and medication adherence, and can also receive patientinformation from the EMR, for inclusion in its analysis and/orcommunicating to the patient. As one example, the server 50 can accessthe EMR to obtain the patient's prescription information and use that insending reminders to the patient and in assessing patient compliance(alternately referred to as adherence) with the prescription.

The system of the invention can also optionally accept usage data fromboth controller 20 and rescue 25 inhalers as well as lung function datafrom a spirometer 28, as schematically shown in FIG. 1. Each of thethree respiratory devices 20, 25, and 28 can incorporate its ownsensing, data storage and/or communications interface as needed tosupply data to the local station 30, although in a preferred embodimentthe inhalers 20 and 25 each use a separate tracking module 10 (in FIG.1, the block diagram shows both inhalers connected to the same trackingmodule 10. This is for convenience of illustration only. Although notshown, each inhaler may have a separate tracking module). Additionally,FIG. 1 shows the spirometer 28 connected with both the tracking module10 and the local station 30. This also is for convenience ofillustration. In one embodiment, the spirometer has its own datacollection and wireless communication device to communicate spirometrydata directly to the local station wirelessly. The data from each of thethree respiratory devices (20, 25, and 28) can be gathered and forwardedto the local station 30 by its own respective module, or in anotherembodiment, data can be collected in a shared tracking module 10, or acombination of shared and dedicated modules.

It is also possible within the scope of the present invention for thesystem to be designed and operated to monitor only lung function datavia a spirometer 28, and to interact with the patient to encourageproper and timely use of the spirometer to provide needed data and tofacilitate anticipation of potential adverse respiratory events.

An example of a tracking module 10 according to the invention isillustrated in FIG. 2, with the tracking module in this examplecomprising a shell 12, made of silicone or other flexible material,which can wrap around a standard inhaler 20 and interlock its ends withone another to be held in place. Alternatively, or in addition, it maybe secured to the inhaler by means of a snap, magnet, moldable metalwire, hook-and-loop fastener such as Velcro® fasteners, and other means.Alternatively, it may be secured over a device without any attachmentdevice, using elasticity to make it cling to the inhaler. In anotherembodiment, the shell may be formed of a rigid material that can besnapped over an inhaler or otherwise installed on an inhaler. The shell12 is shown as having a cap 13 attached to the shell by a flexible cable14. As shown in FIG. 2, the cap 13 can attach to the end of a medicationcanister 15 after the canister is inserted into the body of the inhaler20.

FIG. 3A is a front perspective view of an inhaler 20 onto which has beenmounted a tracking module 10 as shown in FIG. 2. As in FIG. 2, theinhaler with tracking module is in the “use” configuration ready toadminister doses of medication to a user. FIG. 3B shows the inhaler andtracking module of FIG. 3A with the cap 13 of the tracking module 10withdrawn from contact with the medication canister 15 in the inhaler.The configuration of FIG. 3B allows for removal of the canister 15 thatis presently in the inhaler. FIG. 3C shows the same inhaler and trackingmodule as in FIGS. 3A and 3B but shows the actual removal of thecanister 15 so that it can be replaced. Thus, FIGS. 3A-3C illustrate theprocess of removing the cap 13 and removing the canister 15 so that thecanister may be replaced.

Turning now to FIG. 4A, one embodiment of a tracking module 10 is shownin the uninstalled configuration. FIG. 4A shows the outside of thetracking module. The cap 13 is connected to the shell 12 with theflexible cable 14. The cap includes the sensor switch 16 that isdepressed when the user presses on it to force the medication canister(not shown) into the inhaler (also not shown) so that a dose isadministered. Also shown is a sync button 17, the function of which isdescribed below. At the right side of the tracking module is the femalepart 42 of the connector that holds the tracking module in place on aninhaler. At the left side is the male part 44 of the connector. FIG. 2shows how they interact with each other to maintain the tracking modulein its operative position on the inhaler. In this case, the shell 12 isformed of a flexible material so that it may be wrapped around aninhaler and fastened so that it is mounted to the inhaler, as shown inFIG. 2.

FIG. 4B shows the inside view of the tracking module 10 as shown in FIG.4A. It is also in the uninstalled configuration. An additional elementis shown in this figure. Reference numeral 18 indicates a battery cover,under which is located the electronics 300 (not shown, with dashed leadline indicating location) of the tracking module and a battery powersource.

In a preferred embodiment of the invention, the tracking module 10includes:

-   -   a Bluetooth® low energy device, for example, a TI CC2541        Bluetooth 4.0 LE IC;    -   a short-term memory device, for example, the TI CC2541 IC's        internal RAM for holding 30 records of 20 bytes each, requiring        a total of 600 bytes;    -   a pressure activated sensor 16 (in the form of a mechanical        switch, an electro-mechanical switch, a piezo-electric switch,        or some other pressure-sensitive activator) that is activated        when the user depresses the inhaler to take a dose of        medication;    -   an accelerometer;    -   a battery, for example, a CR2032 220 mAH button cell battery        (not shown), located under a battery cover 18;    -   a PCB Board with a Bluetooth® 4.0 LE Module and with two        accessing buttons (one for Press-Count, another for Sync) 300;    -   an external “sync” button 17; and    -   firmware, for example, based on. Bluetooth® 4.0 LE communication        protocol (BLE), enabling Press-Count & Sync button        functionalities discussed below. The communication protocol may        take other forms, such as LAN, BAN, or Zigbee.

In another embodiment, the electronics of the tracking module 10 mayinclude an Intel 8052 processor and a zero-power vibration sensor, suchas model no. LDT0-028K by Measurement Specialties. While anaccelerometer can function as a vibration sensor, an accelerometer isnot a zero-power device and can use far too much power from a smallbattery.

In operation, each tracking module 10 has a unique identification numberand is “paired”/“synced”/“married” to a unique user smartphone (as anexample) such that each tracking module has a direct feedback loop witha single user smartphone (hereafter referred to as “pairing”). Thepairing is performed once, either automatically or using the “sync”button 17 on the exterior of the tracking module, for example, the usermay open the app 46 on the smartphone, tell the phone to find a device,and the app will find the device if the user presses either the syncbutton or puffs when the app is looking to sync with a device. The sametracker can be re-paired with different smartphones.

The tracking module 10 records a date-stamp each time the pressureactivated sensor 16 is depressed (the “DateStamp.”) The switch sensor 16could be provided anywhere on or connected to the tracking module, andnot tied to actual medication dispensing, for the user to press aftertaking a dose of medication. In a preferred embodiment shown in FIGS. 4Aand 4B, the switch 16 mounts to the top of the medication canister sothat the switch is activated each time that the canister is depressed.Alternatively, the operation of the inhaler to deliver a dose could bedetected when the user activates any other mechanical mechanism fordispensing medication. The DateStamp is a record of the date and time ofactivation, preferably associated with a unique “Puff ID.” Since thedosage per activation is fixed and known, no data need be recordedexcept the number of activations and the times at which they occurred.The DateStamp is stored in the internal memory of the tracking module.When a DateStamp is recorded, the tracking module immediately searchesfor the paired device. If the paired device is found, the trackingmodule transmits the DateStamp, the smartphone confirms receipt, and thetracking module returns to “inactive” or “sleep” mode. If proximity isnot immediately found, the tracking module regularly seeks the pairedsmartphone, for example, every 7-10 minutes, or for a thirty secondwindow once per hour, or some other suitable interval. Once proximity isfound, the tracking module transmits all stored DateStamp(s) and returnsto “inactive” or “sleep” mode.

An alternative tracking module 70 configuration is shown in FIGS. 5A,5B, and 5C, designed for use with a Diskus® inhaler 78, which is a DPI.In this case, the tracking module comprises a saddle-shaped shell 72designed to fasten onto the Diskus® inhaler over the exterior portion ofthe inhaler body that rotates. This alternative tracking moduleconfiguration will include the same electronic internal components andwill respond to its pressure sensitive switch 74 and sync button 76 inthe same manner as the HFA model of tracking module 10 shown in FIGS. 2,3A, 3B, 3C, 4A, and 4B. In this embodiment, switch 74 is notmechanically tied to inhaler activation, but is a standalone button thatcan be activated by the user after each dose to indicate that a dose hasbeen delivered. In a different embodiment, an inhaler activation sensingswitch is used in addition to or in place of the standalone switch. Inone embodiment of the inhaler activation sensing switch, an acousticsensor is used that detects the sound of activation of the activationswitch 74. The acoustic sensor would be mounted as part of the shell 72adjacent the activation switch so that the mechanical sound of theswitch making internal contact could be detected.

There are a number of features and advantages that flow from thetracking module 10 (FIG. 2) having the design and operatingcharacteristics as described above. It will exhibit very low powerconsumption due to the combined effects of low energy Bluetoothcommunications and an operational design as a largely passive devicethat spends the majority of its time in an off/standby mode to conservebattery life. For example, the device is ordinarily in an off/standbymode, and when the sensor button is depressed, the tracking module wakesup from standby mode, and attempts to connect with a mobile device forbrief period of time. If it succeeds, the stored data is immediatelytransferred, and the module returns to its off/standby mode. If it isunsuccessful in immediately connecting to a paired mobile device, thetracking module places itself in an off/standby mode and wakes itself atintervals (for example, once per hour) and for durations (for example,thirty seconds) that will not result in significant power consumption.

A further advantage is that, with the tracking module 10 having its owninternal memory, the inhaler 15 and smartphone 30 need not be inproximity when a dose is taken. In addition, the embodiment in which thetracking module shell 12 is made of silicone and wraps around theinhaler 15 instead of mounting on top of the inhaler leads to an elasticand flexible package. Not only is this easier to use, but this structurealso allows the tracking module to fit on different size HFA inhalers aswell as other shapes, including disk-shaped inhalers; for example, theAdvair Diskus® inhaler.

Still further, conventional inhaler practice has been to use one inhalerfor “controller” medication 20, inhaled daily no matter how a patientfeels, to provide sustained patient improvement and prevent attacks andhospitalization, and a different inhaler for “rescue” medication 25,inhaled only when the patient is having difficulty breathing or havingan asthma attack. The tracking module 10 according to the invention canbe used for both controller and rescue medication inhalers.

The “Sync” button 17 permits pairing and data-transmission withouttaking a dose, and the tactile feedback on pressing the switch informsthe user that the switch has in fact been pushed, decreasing repeatedand unnecessary activations.

Additional embodiments include the following:

A vibrate function or audible function is incorporated into the trackingmodule 10 or into the smartphone application 46 that programs thetracking module or the local station 30 to vibrate or sound an alarm atregular intervals if a dose is not taken.

The tracking module 10 is configured to make a sound in order for theuser to locate the tracking module (for example, if the tracking moduleis misplaced in a cabinet or has fallen under a couch, etc.).

The tracking module 10 includes circuitry to monitor battery conditionand is programmed to activate a light or lights to indicate to a userthe existence of a low battery. The tracking module also includes a dosecounter or has access to a dose counter and provides a light to a userindicating that an inhaler medication order should be refilled (e. g.,for example when only a few doses are left). The tracking module isprogrammed to have access to a prescription or data related to aprescription and is programmed to activate a light or to indicate thatit is time to take a dose.

The tracking module includes a dose counter and is programmed to displayto the user the number of doses remaining.

The tracking module 10 has a mechanism or mechanisms other than thepressure sensor switch 16 that detect activation of the inhaler. One isa mechanism that otherwise detects movement of the canister 15 toactivate it to administer a dose of medicine. Another is a mechanismthat senses medication exiting the inhaler, as is described in detailbelow.

Different wireless communication technology is used for communicationbetween the tracking module 10 and the local station 30. In oneembodiment, a WiFi® system is used. In another embodiment, a mobile cellphone network is used. Other wireless communication technologies may beused. In yet another embodiment, direct wireless communication betweenthe tracking module and the network 40 is used.

In another embodiment as is described below, the tracking module 10 isprovided with a flow measurement device so that the tracking modulemonitors not only the number of doses administered but the amount of themedication inhaled from monitoring the inspiratory flow rate and volume.In another embodiment, a wireless spirometer 28 is used to monitor lungfunction to measure how medication use impacts a patient's ability tobreathe.

In one embodiment, the local station 30 comprises an in-home beacon thathas a WiFi® enabled hardware device that plugs into a standard walloutlet and is in a permanent and constant receive mode state. The beaconsyncs to the tracking module either in response to a user pressing thesync button 17, or the pairing could happen in response to detectedactivation of the inhaler. The beacon relays data from the trackingmodule 10 via WiFi® system and the Internet, to a cloud-based trackingprogram application in one embodiment. Local-based programs and otherremotely but non-cloud based programs may be used as needed or desired.

In addition to the tracking module 10, the system of the presentinvention includes a local station 30 (FIG. 1) which, in the preferredembodiment, comprises a smartphone running an application (“app”) 46 viawhich the smartphone will interface with the tracking module andtransmit data as appropriate to the server 50. More than simply storingand forwarding usage data, the application interacts with the patient tofacilitate usage tracking, and to encourage adherence with the patient'sprescription.

In another embodiment, the app 46 programs the local station toconfigure it to adapt user messaging to user behavior. Under thisconfiguration, the local station will deliver more or fewer messagesdependent upon the consistency of user behavior, and to be dependentupon user preferences. In such an embodiment, the user can set his orher notification preferences, and notifications will turn off ifmedication is taken (i.e., good user behavior vs. bad user behavior).Thus, rather than a one-system fits all users, the system is programmedto adapt to each user based on the user's preference and performance. Anillustrative example would be for a system to be programmed to recognizea three-hour time window during which the next scheduled inhaler use isto occur, In such a case, the system is programmed to provide messagesthat are triggered at different times; for example, a reminder one hourin advance of the next scheduled time for inhaler use, a reminder at thetime scheduled for inhaler use, reminders once per hour during thethree-hour window, and a “dose missed” message after that. The systemsends reminders at all of these events for a patient with a badadherence record, and to the patient with a good adherence record, theprogram only sends one reminder shortly before the end of the three-hourwindow. In another embodiment, the content of the messages differ forpersons with good adherence vs. persons with bad adherence. Theprogramming provides a Settings menu with which the patient electsbetween more frequent and less frequent reminders, and the system thentakes into account both the user preference and the adherence history indetermining the frequency of the reminders; i.e., how many and whichreminders are to be sent.

FIGS. 6-10 illustrate exemplary screens that are presented to a userduring operation of one embodiment of an app 46 (see FIG. 1) for thesystem. In a preferred embodiment, the app employs a dynamic interfacethat communicates through automated (but intelligent) messagingresponsive to particular user adherence and response rates. The appemploys a red-yellow-green alerting and engagement output that isconsistent with Pulmonary (Asthma and COPD) Clinical Guideline at-riskthresholds (red-yellow-green). The app uses the smartphone 30 clock tocalculate most auto-messaging, or the messages can be generated at thecloud server 50 (FIG. 1) and sent to the smartphone 30 via text or pushnotification. The functions contained in each screen are describedbelow. FIGS. 6-7—are examples of screens presented during initial setupof the app. FIG. 6 shows the initial sign in or register screen 180 forinitiating the app. FIG. 7 is the register screen 182 that permitspairing of the app with a tracking module. FIG. 8 shows the symptoms andtriggers module 184 that allows for monitoring and alerting ofenvironmental triggers.

FIGS. 9 and 10 show the home page interface 186 which is dynamic andconfigurable to include patient alerting and calls to actions. This caninclude initiating an emergency communication, which can be a telephonecall, SMS, or other text message, email, etc., to a physician or otherhealthcare professional, a caregiver, or other emergency contact person.It can also include prompts to track lung function, patient educationalvideo and written content, as well as an aggregated red-yellow-greenacute event alerting based on adherence, lung function, environmentaland other digital biomarker inputs.

In other embodiments, the above-discussed screens can be modified, oradditional screens added to show an alert to the patient of a potentialadverse event or other complication, an alert regarding a change in thetreatment regimen, an alert to the patient to contact the physician,etc.

While the invention has thus far been described primarily in the contextof an inhaler, it can be used to track spirometer 28 usage alternativelyor additionally, as briefly indicated above with regard to FIG. 1. Aspirometer is used to assess lung function, with the user blowing intothe spirometer that then measures the strength and volume of anexhalation and/or inhalation. These measurements are transmitted to alocal station 30 and/or to remote server 50. It is also possible for atracking module 10 to be paired with a spirometer so that the trackingmodule stores respiratory data reflecting spirometer measurements. Thisis done with a tracking module dedicated to the spirometer, or separatetracking modules for spirometer and inhaler, or where the spirometer hasthe elements of a tracking module (for example, activation sensor,internal memory, wireless communication component) incorporated withinthe spirometer. In this embodiment, the interactive user interfacepresented by the local station has a separate interface dedicated tospirometer usage, or if inhaler usage data is collected in addition tospirometer measurements, a single interface addresses both inhaler andspirometer usage.

In either case, the local station 30 (for example, a smartphone)displays images that correlate to the user's inspiration or expirationwith the spirometer 28. For example, an image of a birthday cake withlit candles where the candles flicker and are extinguished as a userblows into the spirometer can be used to give the user feedback whenusing the spirometer. Other animations may be used to provide feedbackto the user.

By tracking these lung function measurements over time, trends areidentified. Response to different inhaler treatment regimens are seen,deterioration of lung function suggesting imminent respiratory event canbe spotted, and predictive modeling is used with all available data topredict potential future events/issues more reliably and provideappropriate messages to the patient and/or healthcare support to preventsuch events.

By way of example, the system generates communications relating to apotential exacerbation, potential complication, potential acute event,effectiveness of current usage plan and/or potential change to the usageplan. The patient, in a Settings menu for example, designates differentpersons to receive communications, for example, a caregiver designatedto receive communications regarding compliance level, potential acuteevents, etc., and a physician or medical practice receivingcommunications relating to potential acute events and alsocommunications relating to the effectiveness of a current usage plan orpotential change to that plan. For example, a communication to thehealthcare professional relating to the current or potential usage planwould include data on usage and lung function and also includes analysisof that data. A further option would be designating an insuranceprovider to receive communications regarding a prescription refill.

The smartphone app 46 in another embodiment instructs the user on properuse of the spirometer 28 and provides incentives for proper usage ifdesired. The spirometer has its own internal memory, so it is usablewhile not in proximity to a local station 30 or to a tracking module 10,and data is synced at a later time either to a tracking module ordirectly to a local station.

Turning now to FIG. 11, there is shown a cross-section view of a typicalmetered-dose inhaler 100. Metered-dose inhalers (MDIs) usually havethree main parts: a mouthpiece 102; a canister of propellant withmedication suspension 106; and an L-shaped plastic body 108 within whichthe canister is located for use. The canister is activated by pressingits bottom surface 190 into the body of the inhaler. A metering valve inthe canister then controls an aerosol 116 of deagglomerated medicationthat comes out the mouthpiece for user inhalation. Alterations of theseparts are possible.

In FIG. 11, an “inhaled-air” passage 110 is located between the outersurface of the canister 106 and the inner surface 107 of the inhalerbody 108. When the user wants to inhale a dose of the medication fromthe canister, the user places his or her lips over the mouthpiece 102and begins inhaling just before the time that he or she presses the topof the canister into the inhaler body to activate the canister andproduce the spray or “puff” 116 of medication. By beginning the inhaleaction just before the canister is activated, the user will more likelyinhale at the same time that the canister sprays the aerosol 116 ofmedication thereby receiving the entire dose of medication from thecanister across the user's breathing passages and into his or her lungs.This inhaled-air passage 110 is upstream 192 from the location 115 wherethe medication spray 116 is released by the canister, as shown in FIG.11. The spray 116 is therefore “downstream” 194 from the canister'sspray. As the user inhales, he or she will draw in ambient air 118through the inhaled-air passage 110 and into the lungs of the user.

Although the activated canister 106 sprayed a dose of medication 116,and this canister activation can be detected, it would be more desirableif there were evidence that indicates the medication was inhaled by thepatient. One way to develop such evidence is to measure the flow of airoccurring in the inhaled-air passage 110. Detecting such a flow of airwould tend to indicate that user inhalation is occurring. The existenceof a flow of air through the inhaled-air passage 110 in the inhalationdirection at the same time that the canister 106 was activated alsotends to indicate that a patient has inhaled the dose 116.

In accordance with FIG. 11, a pressure sensor 114 has been located inthe inhaled-air passage 110 and will measure the flow of air through thepassage. The measurement of pressure in the passage 110 can result in aflow determination. If the user is inhaling, the pressure will decrease.If the user is exhaling the pressure will increase. Measuring andanalyzing this pressure decrease data, including the time the pressuredecrease started, the length of time of the pressure decrease, and thetime of activation of the canister for the spray of the dose ofmedication 116 can even more strongly lead to a conclusion that theinhaler medication reached the patient's lungs. This data can also beused to develop a quality measurement of the patient's inhalation(“quality of inhalation”) and provide information on the patient'sinhalation technique. The embodiments of FIGS. 15 and 16, discussedbelow, show how an embodiment of a tracking module in accordance withaspects of the invention provides this data.

Other factors may affect the quality of inhalation of a user. Some areshown in FIG. 1 which include environmental factors, such astemperature. Pollution and allergens in the immediate environment canaffect the inhalation quality. Particulates in the air and medicationsthe patent may be taking can also affect the quality of inhalation.

FIG. 12 presents a view of an embodiment of another tracking module 200in accordance with aspects of the invention. The tracking module 200shown in FIG. 12 operates similarly to that shown in FIG. 2 but has adifferent configuration for mounting to an inhaler shell and canister.In this figure, there is shown a tracking module having a body 134 witha front flap 122 that is configured to be bent over the top of aninhaler in which a medication canister has been installed (not shown) tohold the inhaler in the body of the tracking module. The body includestwo ears 124 that protrude from the body to engage two holes 126 of thefront flap when the front flap is mounted to an inhaler. The trackingmodule has a dose sensor switch (not shown) similar to that in FIG. 2and is connected with battery power and other electronics 128 withelectrical conductors 132. In this embodiment, the tracking moduleincludes a protrusion 60 that is positioned between the dose detectorswitch 16 and the top of the canister to make contact with the top of acanister when the tracking module is mounted to an inhaler (see FIG.14). When the dose detector switch 16 is pressed by a user towards thetop of the canister 106, the protrusion will force the canister into theactuation position.

FIGS. 13 and 14 show additional details of the tracking module of FIG.12. FIG. 13 is a top view showing more clearly the sensor switch 16 thatsenses the pressure exerted on an inhaler canister when it is pressedinto an inhaler shell to deliver a dose of inhaler medication to a user,as is explained in detail above. Part of the electronics 128 can be seenalong with part of the front flap 122. FIG. 14 shows the tracking modulealso engaged with an inhaler 100 in which a medication canister has beeninstalled. The tracking module includes a protrusion 60 located as partof the tracking module between the sensor switch 16 and the top 136 ofthe canister 106 that engages the top 136 of the inhalation medicationcanister for actuating the canister. The inhaler shell 108 is visiblewithin the tracking module. In this embodiment, the tracking module hasan outer shape with shallow detents 138 for receiving a patient'sfingers to assist the patient in firmly grasping the tracking moduleduring use of the inhaler. Similarly, the inhaler activation detectionswitch 16 is located in a shallow depression 144 at the top 202 of thetracking module to assist the patient in more easily locating the top ofthe canister during use of the inhaler so that the patient can activatethe medication canister 106.

The detents 138 shown in FIGS. 14 and 15 may also house a biometricdevice or devices. These may take the form of a fingerprint reader as anexample Other biometric sensors may be used on the tracker module andmay be placed where room exists. In such a case where a biometric readeris used, the memory of the tracking module would contain anidentification number or code for that tracking module and a localdevice that has been paired with that tracking module would store thetracking module's identification. Before use, the biometric sensor 138would take the potential user's biometric data and forward it to thelocal device. The local device may compare the biometric data against adatabase of the user's and authorized tracking modules. If thispotential user is not in the data base as authorized to use thistracking module, the local device may indicate as such on a displayscreen viewable by the potential user. Other arrangements foridentifying potential users from biometric data may be employed.

FIG. 15 is a front perspective view of the tracking module 200 of FIG.14 also showing the tracking module being mounted to an inhalationcanister 106. In this view, the detector switch 16 used to detectactivation of the inhalation medication canister by a patient pushingthe canister into its shell 108 as discussed above is shown as a roundedsurface in contact with the top 136 of the canister. Also shown in thisfigure is an accelerometer 120 mounted at the tracking module and aproximity sensor 130 mounted to the front flap 122 of the trackingmodule and mounted so as to sense the tracking module being in theproximity of a patient. The accelerometer can have multiple uses;however, one of those uses is to sense movement of the inhalerconsistent with taking a dose of the inhalation medication from thecanister. The data from the accelerometer is stored along with the timethe data was produced and is compared to the time recorded for when thepatient took the most current dose. Accelerometers require power tooperate which can drain the battery of the tracking module.Consequently, the accelerometer may remain in an off, or non-powered,mode until the dose sensor switch 16 if the inhaler is activated, oruntil a vibration sensor is activated. Accelerometer data is useful todetermine if the user has a good inhaler technique. For example, it canshow if the patient is holding the inhaler upright when it was used. Ahealth care practitioner (HCP) can study this data and advise the userthat he or she must be upright when administering a dose of inhalermedication or it may not reach the lung successfully.

Although not shown in FIG. 15, a zero-power vibration sensor can be usedto determine if the inhaler is being readied for use. Such sensors areavailable from multiple sources. One such sensor that has found to beuseful is model no. LDT0-028K by Measurement Specialties of Hampton, Va.23666. Because they are “zero-power” sensors, they do not drain thetracking module's battery of power when the tracking module 200 is notin use. However, the sensitivity of such a sensor must be set so thatordinary non-use activities do not activate it. For example, the sensorshould be set so that ordinary movements experienced by a user carryingthe tracking module in a purse or backpack do not cause the trackingmodule to be powered up. Another advantage to a zero-power sensor is thedetection of an intentional shaking activity by a user in readying theinhaler for use. Some inhalation medications require the user to shakethem before use and in this case, the sensitivity of the zero-powervibration sensor can be set to detect such movement and the time ofdetection of such shaking action is recorded as data to show that theuser performed it. The accelerometer may also, or alternatively, be auseful device for detecting the shaking once it is powered up.

FIG. 16 is a partially cutaway view of the tracking module 200 of FIG.15 showing more detail of the dose sensor switch 16 located in contactwith the top 136 of the canister 106. In this embodiment, the dosesensor switch 16 is pressure activated in that when a user presses on itto activate the canister to spray a dose of medication out the inhaler,the dose sensor switch is activated, and its activation is recorded bythe processor of the tracking module 200. The shallow depression 144 inwhich the dose sensing switch is located is shown.

Further in FIG. 16, the dose sensor 16 includes a flow sensor mountingextension portion 206 that makes contact with the top 136 of thecanister and extends towards or into the inhaled-air passage 110. Inthis embodiment, the pressure sensor 114 is attached to the end of theextension portion 206 so that when the tracking module is properlymounted to an inhaler and the cap is in contact with the top of thecanister, the extension portion places the flow sensor at or in theinhaled-air passage as shown. As discussed previously, this is anupstream 192 location of this particular flow sensor in that ambient airwill be pulled past it on its way to the mouthpiece of the inhaler to bemixed downstream at the convergence point 115 with medication sprayed bythe canister into the mouthpiece 102 as shown in FIG. 11. In thatregard, it is positioned upstream of the medication spray from thecanister. The flow sensor at this location should provide a moreaccurate indication of the inhalation of the user. In another embodimentdiscussed below, a downstream flow sensor may be used in place of theupstream flow sensor or in conjunction with it.

FIG. 16 is not drawn to scale but is provided only for the purpose ofillustrating where the various elements of the figure lie in relation toeach other. The pressure sensor 114 resides in the inhaled-air passage110 and can sense pressure there. When the air 112 is drawn through theinhaled-air passage 110 by the user's inhalation, the pressure willdecrease, and that pressure decrease will be sensed by the pressuresensor 114. The decrease in air pressure in the passage indicates that aflow of air through the passage exists thereby indicating that theinhaler is being used to administer a dose or “puff” to a patient.Wiring for the flow sensor 114 is provided along with the wiring for thesensor switch 16 through the electrical conductors 132 (FIG. 12).

The flow sensor 114 is also able to detect an exhalation of the userprior to an inhalation. Such may occur when a patient is preparing foruse of an inhaler and is often recommended by HCPs. It is not necessaryfor the user to exhale through the inhaler, but some users may do so.The user may hold the inhaler in his or her mouth, exhale through theinhaler to empty his or her lungs, begin inhaling, then press thecanister into the inhaler to activate it, and continue inhaling themedication from the canister. In such an arrangement, the flow sensor114 would output signals indicating the flow of exhaled air, then a flowof inhaled air. This data is recorded by the tracking module processorfor later review if needed. By using a pressure sensor, the direction offlow is easily determined. When the pressure returns to ambientpressure, the recording of data from the flow sensor 114 would cease inthis embodiment.

A sensor useful for the above flow sensing function is the OmronBarometric Pressure Sensor contained in the Omron Evaluation Kit F2D3.See http://omronfs.omron.com/en_US/ecb/products/pdf/en_2smpb_02e.pdf.The sensor is sensitive enough to detect a pressure change when thepatient inhales when taking the dose from the activated canister. Othersensors may be used and other locations for the sensor may be used. Aflow sensor or pressure sensor of a different type that is capable ofdetermining that air is flowing through the inhaled-air passage 110 mayprovide the same results as the barometric sensor mentioned above.Whether the sensor is a pressure sensor, either barometric or other, oran acoustic sensor that is sensitive enough to detect the sound of airrushing past it caused by breathing of the patient, it should be of ashape, small size, and location so that it does not distort or interferewith the user's ability to properly inhale and/or exhale through theinhaler.

The measurement of flow of air through the passage 110 results in aquality measurement “Q” in labeling the patient's inhalation. The outputof the pressure change sensed by the barometric sensor is compared to adatabase to determine if this particular inhaled dose was an inhalationthat was light, medium, or heavy. A base line pressure would be recordedwhen the canister is shaken. Then pressure change would be measured asthe dose button is pressed. The change Δ in atmospheric pressure ismeasured as soon as the canister activation button (dose button) 16 ispressed. The Δ would be compared to curves stored in a database of Δs todetermine the quality of the dose. However, the quality of theinhalation may be graded in a way that is different from “light,”“medium,” or “heavy.” It may be graded as “unacceptable,” “acceptable,”or “good.” The purpose is to grade the relative quality levels of aninhalation. Likely aspects of quality are: the inspiratory flow rate(for example, “acceptable”=≥10 liters/minute (L/m) and “good”=≥20liters/minute); the timing between inhalation and puff actuation of thecanister (did inhalation start before activation of the canister); andthe length of time of the inhalation.

The pressure/flow sensor 114 provided in the embodiment of FIG. 16 thatis attached to the removable tracking module provides the ability to usecommon inhalers that are readily available today. Today's MDIs aredesigned to have the inhaled-air passage 110 between the canister 106and the inhaler 108 for inhalation purposes. Designing the trackermodule 100 so that it has the pressure/flow sensor 114 built into theextension portion 206 of the detector switch 16 that interacts with thecanister and that permits positioning the sensor in the air passage asshown in FIG. 16, enables those common inhalers to continue to be used.Fortuitously, the pressure sensor is easily removed from the inhaled-airpassage 110 when the cap 13 or cap portion (FIG. 2) or front flap 122(FIG. 11) of the tracker module 10 is disengaged from the canister forreplacement of the canister.

Referring now in more detail to FIG. 15, an inhaler tracking module 200is shown mounted around the inhaler 108. The tracking module has beendesigned to mount around the outside of the outer shell or body 108 ofthe inhaler 100, similarly to the shell 12 shown in FIGS. 2, 3A-3C, and4A-4B. The tracking module operates similarly to that of the earlierfigures. Many MDI's require the patient to shake the medication canisterbefore using. Because the canister is installed in the inhaler device,the user will shake the inhaler device with the tracking module mountedto it. The patient then exhales completely, starts to inhale and pressesthe canister of the inhaler to expel the medication all the while he orshe is inhaling. The present HeroTracker® tracking module 10 from CoheroHealth, Inc. of New York, N.Y., becomes operationally active (“wakesup”) by the patient pressing a dose sensor button 16 located in contactwith the top 136 of the inhaler canister 106 that will administer thedrug. At this time, the inhalation procedure might already be happeningsince the patient may begin inhalation before pressing the dose button.However, embodiments disclosed herein show and describe differentfeatures.

As described above, the tracking module 200 in the embodiment of FIG. 15is awakened by a vibration sensor 164 (FIG. 18). The vibration sensormay also be used to verify that the patient shook the canister asrequired and to record how long the canister was shaken. Theaccelerometer 120 may also be used for this purpose. If there is aminimum time required for canister shaking, data from the shake sensoror accelerometer will assist in monitoring the inhaler technique of thisparticular user. It would be expected that a dose would be administeredsometime after the canister shaking. Waking the tracking module by theshaking sensor signal before the canister button 16 is pressed would“awaken” (power up) the processor of the tracking module to measure anyexhalation and inhalation time from signals provided by a flow/pressuresensor. If there is no drug delivery within a preset time afterdetection of shaking, the tracking module would go back to sleep; suchas if there were some other vibration that was not consistent withcorrect procedure. A vibration sensor in one embodiment is mounted tothe same printed circuit board as the processor.

As briefly described above, the vibration sensor 164 in one embodimentis a zero-power device and is mounted to the circuit board on which theprocessor is mounted. A pendulum connecting to a contact would suffice.Also, a suspended weight hitting a piezoelectric device would causeenough voltage to wake up the processor of the tracking module 10. Othermethods could work if they were ultra-low power, such as less than 5microamperes. A vibration threshold that triggers a processor wake upwould need to be selected that causes the wake-up but does not cause awake up when the inhaler is subjected only to normal handling. Thisfeature minimizes the power consumption.

Vibration sensors are available from a number of sources and function indifferent ways. A preferable vibration sensor for the tracking module ofone embodiment is a zero-power device. That is, the vibration sensor isnot powered to operate. The pendulum approach described above is oftenzero power. The bob of the movable pendulum forms one contact of anelectrical circuit and a plurality of contacts surrounding the movementarc of the bob of the pendulum provide the other contact. The electricalcircuit that is created when the bob touches an electrical contactcauses an interrupt to the processor which then turns the electronics onof the tracking module.

Such vibration sensors are common and are well known to those of skillin the art. Consequently, no further details concerning their structureor operation are provided here.

Another sensor that may be used for detecting vibration or shaking,depending on power requirements and the limitations of battery power, isa three-axis accelerometer 120 (shown in block form). An accelerometercan sense shaking of the inhaler as well as the time of day that theshaking occurred, the intensity of shaking, and the length of time ofshaking. These can be sensed and stored as data by the tracking moduleprocessor and local memory. Such data can also be used to affect thequality determination of the inhalation. Some accelerometers remain in asleep mode but are promptly awakened upon sensing a shaking motion of acertain intensity. Another sensor usable for the purpose of sensingshaking is a piezoelectric device that produces an electrical signalwhen it receives an electrical shock. Such a device is available fromMurata having a part no. of 7BB-20-3.

In another embodiment, a dynamic accelerometer 120 is used to measuregravitational pull to determine the angle at which the inhaler is tiltedwith respect to the Earth. The inhaler can thereby record in whichdirection, or orientation, the mouthpiece is pointing when a dose isadministered. In the embodiment described above, the accelerometer isactivated when it detects shaking of a certain level of intensity. Inanother embodiment, the accelerometer is in the off mode until the dosesensor 16 (button switch) is pressed to administer a dose of inhalermedication from the canister. The accelerometer is immediately powered,and its signals are stored along with the dose detection signal in thememory. By sensing the orientation and movement or non-movement of theinhaler with the accelerometer, it can be determined if the dose waslikely administered to a patient or was mistakenly given, such as bydropping the inhaler on the floor, which can be detected by theaccelerometer. Various accelerometers are available from multiplemanufacturers, including those used in mobile telephones.

In another embodiment where there may be concern about whether atracking module 10 is awake for use in tracking a dose administration, avisible light source mounted in the tracking module is used. When theprocessor of the tracking module 200 is active and operational, a smallgreen light is powered on that is easily visible to the user. Toconserve battery power, the light is very efficient; i.e., a small greenlight emitting diode (LED) is usable. In this embodiment, the trackingmodule provides an indication if the processor is operational and isusing battery power when the user is not intending to use the inhaler.Such a condition may exist if the inhaler is placed in a user's backpackand experiences rough handling. The shaker sensor signal may result inthe processor becoming operational and awaiting the dose sensor signal.The user can then recognize that the inhaler is needlessly using batterypower and decide to store the inhaler in a different location that wouldnot experience rough handling when it is not being used.

Also shown on FIG. 15 is a proximity sensor 130 mounted to the frontflap 122 of the tracking module 200. The purpose of the proximity sensoris to detect whether the inhaler 100 is near a user when the canister106 is activated to deliver a dose of the inhaler medication. Oneembodiment of a proximity sensor comprises an infrared (IR) sensor thattransmits a beam. As shown in FIG. 15 in block form, an infrared device130 (transmitter/receiver) is located at the front flap 122 of thetracking module. The proximity sensor is oriented so that its beam isdirected in the direction of the mouthpiece 102; i.e., towards a userwho would be using the inhaler and would put the mouthpiece in his orher mouth. The sensor will detect a return signal if the user is in thecorrect position with his or her mouth over the mouthpiece when thecanister 106 is activated. Such an IR sensor can be obtained from VishayAmericas, Inc., One Greenwich Place, Shelton, Conn. 06484,https://www.visha.com/.

The IR sensor 130 (proximity sensor) can determine that it and theinhaler, are near the user of the inhaler when the canister isactivated, and a dose was dispensed. This tends to indicate that theuser has taken a dose. However, if there is no response to thetransmitted IR beam, it may mean that the inhaler was in the wronglocation and the user did not take a dose from the inhaler, or thatsomething else is wrong.

In another embodiment, the IR sensor 130 has both near field and farfield modes and its data is provided to the tracking module's processor.In another embodiment, a second IR sensor is used for the far fieldwhile the sensor shown in FIG. 15; i.e., sensor 130, is used for nearfield. In the far field operation, the IR sensor field extends many feetor meters around the tracking module to detect the existence of a humanwithin the field. If no human is detected for a certain amount of time,the data from the IR detector will indicate as such and the processor ofthe tracking module will turn off the tracking module. In thisembodiment, the far field IR sensor is solely used to turn off thetracking module so that battery power can be conserved. Thus, the farfield IR sensor or sensor mode is not activated until the trackingmodule is activated, such as by a user pressing the dose activationswitch 16 or by a vibration detector.

To briefly review, the tracking module 200 of FIG. 15 is similar to thatof FIGS. 2, 3A-3C, and 4A-4B and the description accompanying thosefigures. In accordance with aspects of the invention, there is providedin this embodiment a Bluetooth® low energy-enabled (BLE) inhalertracking module that connects to or is integrated with an MDI andcontains sensors to track canister activation 16, mouthpiece contact,orientation 120, proximity to a user 130, and air flow rate sensor 114in the medication chamber of the MDI. This combination of sensors wouldprovide greater confidence that both the activation and release ofmedication from the canister occurred along with an indication that theMDI was correctly inserted in the patient's mouth for a sufficient timefor the patient to complete inhalation of the dose and have that dosecross his or her airways and end up in the lungs. The same or similarprinciples apply to the Diskus® inhaler shown in FIGS. 5A, 5B, and 5C.

Referring now to FIG. 17, the inhaler 100 includes a capacitive touchsensor 140 and a micro-electromechanical system (MEMS) pressure/flowsensor or sensors 142 integrated into the MDI of the figure to capturedata indicating correct patient technique in medication inhalation. Inthis embodiment, there is a capacitive touch sensor 140 on the top andbottom (not shown) of the mouthpiece 102. These capacitive sensors willprovide data on the proper positioning and mouth contact with theinhaler during a medication canister activation. The flow sensor 142will provide data measuring air/medication flow rate during actuationand medication release to indicate quality of inhalation. These sensorsare located on the actual inhaler as opposed to being mounted to atracking module that can be mounted go an inhaler and removed from it. Auseful MEMS flow sensor is available from Omron Electronics as partnumber 25MPP-02.

The above principles also apply to mounting a pressure sensor with aDiskus® DPI shown in FIGS. 5A, 5B, and 5C. The Diskus® inhaler made byAdvair also has an inhaled-air passage at which a pressure/flow sensoris mounted in another embodiment.

FIGS. 18, 19, 20, and 21 show the use of an air flow control device, inthis case a cylinder closed at one end, the purpose of which is tocontrol or restrict the air intake for an inhalation so that inhalationrate and volume can be more accurately determined.

FIG. 18 is a perspective, partially cutaway view, of an air flowcylinder 302 placed over the top of the inhaler 136 having a canister106 installed in it for use in detecting flow rate of inhaled air duringan inhalation. In this embodiment, the closed end 308 of the cylinderhas an arc-shaped orifice 304. The orifice shown in FIGS. 18-21 is meantto restrict the flow of ambient air into the inhalation air passage 110so that an accurate of flow rate can be determined. Care must be takenin selecting the orifice so as not to make if difficult for users toperform an inhalation, or to distort the inhalation.

FIG. 19 is a top view of the air control device 302 of FIG. 18 whichshows in this embodiment that the orifice has a circular shape 306. Thefigure also showing the pressure sensor 114 attached to the inner wallof the inhaler shell.

FIG. 20 is a partially cutaway view of FIG. 18 showing a circular-shapedorifice 306 in the air control device 302 closed end 308.

FIG. 21 shows an embodiment of an air control device 328 built into atracking module 230 with an orifice 330 placed over the cylinder of theair control device, the dimensions of the orifice being known so thatflow rate can be determined from measured pressure. In this embodiment,the cylinder 328 of the air control device includes a ridge 332 on itsinner surface. This ridge can be used to align an inhaler within the aircontrol device so that the orifice 330 will be positioned above thepressure sensor 114 mounted to the inside surface of the inhaler wall.In this case, the tracking module is not shown to have a built-inpressure sensor; however, in another embodiment, one would be positionednear the orifice so that a pressure sensor may be located in the inhaledair passage below the orifice. In such an embodiment, the trackingmodule may be reused with different inhalers.

Referring now to FIG. 22, there is shown a block diagram of anembodiment of a tracking module 150 in accordance with different aspectsof the invention reviewed above. A dose detector 158, accelerometer 120,vibration sensor 164, pressure/flow sensor 114, and proximity sensor 130are connected with a processor 152 that is part of the tracking module150. The processor contains a PC clock timer for the sensors, and inthis embodiment, contains an algorithm for battery life. In theembodiment shown, the accelerometer, pressure/flow sensor, and theproximity sensor are all interconnected with the processor on an I² bus170 with the processor having an I² clock timer. This results in greaterefficiency in data transfer. However, other embodiments are possible.

In a different embodiment similar to FIG. 22, there may not exist bothan accelerometer 120 and a vibration sensor 164. In this differentembodiment, only a vibrations sensor 164 would exist. And in yet anotherembodiment, the vibration sensor 164 would not exist but theaccelerometer would. At present, the power requirements ofaccelerometers are relatively high for a battery-powered system but inthe future, the power requirements for accelerometers may drop and theymay become more useful for battery-only powered devices.

A “SYNC” command 162 signal is also shown, which would originate fromthe switch 17 located in the tracker module (FIG. 2). In anotherembodiment, fewer or more sensors may be connected with the processor.The tracking module also includes a non-transient memory 154 in whichprograms for the processor and data may be stored. A communicationscomponent 156 is also in contact with and is controlled by theprocessor. The processor, memory, and communications component are alldescribed above in relation to the PCB Board and Bluetooth® module.Although particular components and their sources of purchase have beendisclosed, other components that function the same or similarly andwhich are available from other manufacturers or sources may besubstituted for those mentioned herein.

In one embodiment, the processor monitors the dose detector for a dosedetector signal. The processor also monitors the vibration sensor, theaccelerometer, the flow sensor, and the proximity sensor. Data from allof these devices are stored in the memory along with a timestamp. Onepurpose of this timing is to extend the life of the battery in thetracking module. In other embodiments, different timing may be used forreceiving and storing sensor data.

FIG. 22 shows various sensors in block form as being part of thetracking module 150. Additionally, the tracking module includes acommunications component 156, in this case a Bluetooth® low energy (BLE)device, a memory 154, a battery 160, and a PCB Board on which theprocessor 152 is mounted, among other components. Wiring of the sensorsto the PCB Board is not shown in the figures because it is believed thatone of ordinary skill in the art would realize a workable means ofconnecting the sensors to the PCB Board. Therefore, no details of wiredor wireless connections are provided herein. In the embodiment of FIG.18, the processor also runs an algorithm for monitoring battery life.Many such algorithms exist and consequently, no further details areprovided here.

Turning now to FIG. 23, another embodiment of a tracking module 250 isshown. The tracking module is similar to the embodiment of FIG. 15except that in this case, the tracking module includes a built-in spacer252. A spacer is a device that attaches to a metered-dose inhaler andhelps to deliver the medicine to the airways of the user's lungs insteadof the mouth. This helps the inhaler medication work better and lessensside effects such as candidiasis (thrush) and dysphonia (hoarseness).“Spacer” is a generic term for any open tube placed on the mouthpiece ofan MDI to extend its distance from the mouth.

The contents of an MDI are under pressure and are released quickly,making it more difficult to coordinate inhalation of the particles. Thespacer chamber suspends these particles until the user inhales, reducingthe amount of coordination required to inhale the particles, thus easingthe delivery of medication into the lungs. These devices are recommendedfor all children who have difficulty coordinating breathing and the useof the inhaler correctly. The purpose of the spacer chamber is to holdthe medication released from the MDI so that a child has the time tomore effectively inhale the medication.

In FIG. 23, the tracking module 250 is shown mounted to an MDI inhaler254 having a medication canister 256 installed. The spacer 252 has amouthpiece 258 and a flow passage 260 shown in dashed lines. Thetracking module is designed so that the inhaler 254 is inserted with themouthpiece sliding into the spacer in alignment with the flow passage260 of the spacer. In this embodiment, the flow passage of the spaceralso includes a flow sensor 262. The wiring 264 for the flow sensor isbuilt into the spacer wall and connects with the electronics of thetracking module which is similar to the embodiment shown in FIG. 12. Theflow sensor in this embodiment is referred to as a downstream flowsensor because it is downstream of the point where the canister spraysits medication into the inhaled air of the user. This point is shown asnumeral 194 in FIG. 11. The data produced by the flow sensor 262 will bestored by the processor of the tracking module and forwarded to theremote server 50 (FIG. 1). This downstream air flow can be used todetermine the user's inhalation technique.

FIG. 24, presents an additional embodiment of a tracking module 280having a built-in spacer 282 mounted to an MDI inhaler 284 having amedication canister 254 installed. The spacer has a mouthpiece 288 and aflow passage 290 shown in dashed lines. The tracking module is designedso that the inhaler 254 is inserted with the mouthpiece sliding into thespacer in alignment with the flow passage 260 of the spacer. In thisembodiment, the flow passage of the spacer also includes a flow sensor262. The wiring 264 for the flow sensor is built into the spacer walland connects with the electronics of the tracking module which issimilar to the embodiment shown in FIG. 12. The flow sensor in thisembodiment is referred to as a downstream flow sensor because it isdownstream of the point where the canister sprays its medication intothe inhaled air of the user. This point is shown as numeral 194 in FIG.11. The data produced by the flow sensor 262 will be stored by theprocessor of the tracking module and forwarded to the remote server 50(FIG. 1). This downstream air flow can be used to determine the user'sinhalation technique.

FIG. 25 is a block diagram of the electronics 300 of an embodiment of atracker module in accordance with aspects of the invention. In thisembodiment, an Intel 8052 processor 302 is shown. This processor ismounted on a circuit board that is located in the tracking module atnumeral 128 in FIG. 12. The same circuit board may include theBluetooth® transceiver 304, the Bluetooth® antenna 308, and the timingcrystals 306. The battery power source 310 may or may not be located onthe same circuit board. The Bluetooth® wireless communication technologyis used for communication of data with the local station 30 in oneembodiment, which may take the form of a smart device such as a smartphone. The timing crystals 306 are used to provide more accurate timedata for events involving the tracking module. As an overview, the Intel8052 processor includes a Bluetooth® (BLE) controller, on board timers,event counters, interrupt controllers, and a memory. The processor 302receives signals from the sync switch 17, the vibration sensor 164, andthe event switch 312. The event switch is meant to include a wake-upsignal from a vibration sensor or accelerometer, for example. It alsoincludes a dose sensor signal indicating that the user has pressed thecanister into the inhaler to receive a dose of medication.

FIG. 26 is a block diagram showing both mechanical and electricalcomponents of an embodiment of a tracker module 350 in communicationwith an app 352 running on a smart device 354 such as a smart phone. Box130 is labeled as “User Sensor” and includes an IR sensor, a capacitivesensor, or an acoustic sensor, or other. An accelerometer 120 is alsoshown. The figure also shows various communication approaches from thetracking module to remote devices for transmitting data from the trackermodule to a remote memory or memories for storage and for referencelater. As shown they include BlueTooth wireless (BLE), a subscriberidentity module card (SIM), WiFi® local area network, and GPS. A GPS(global positioning system) satellite-based navigation system is shownin the figure and would be usable for determining the position of thetracker module.

Although described and shown as primarily an added-on item to be mountedto an existing inhaler, the tracking module may also be built into,fully integrated into, or at least partially integrated into an inhaler.

As a general description and only as a point of reference and not ofdefinition or limitation, in one arrangement a “cloud” server is avirtual server (rather than a physical server) running in a cloudcomputing environment. It is built, hosted, and delivered via a cloudcomputing platform via the Internet, and can be accessed remotely. Theyare also known as “virtual servers.”

The app 46 can be downloaded to a device or can be run from a remotedevice. Other methods for running the program can be used and thedisclosure is not meant to be limited to any particular location of theapp.

“Cloud computing,” often referred to as simply “the cloud,” is thedelivery of on-demand computing resources that can include everythingfrom applications to data storage centers. They are reached over theInternet on a pay-for-use basis. Cloud computing resources are typicallyowned and operated by others and the actual hardware of servers andmemories are often in remote locations. With public cloud services,users do not need to purchase hardware, software, or supportinginfrastructure, which is owned and managed by cloud computing providers.One major cloud computing provider has cloud “campuses” located in NorthCarolina, Oregon, Nevada, Ireland, and Denmark to provide a globalinfrastructure. Some of the cloud campuses have on-site energy sources,such as solar cells, wind-driven generators, or fuel cells.

A cloud “platform” provides a cloud-based environment with everythingrequired to support the complete lifecycle of building and deliveringweb-based (cloud) applications without the cost and complexity of buyingand managing the underlying hardware, software, provisioning, andhosting.

As used herein, “flow sensor” is used in a general sense and includesdevices that are usable to sense flow. For example, a “flow sensor” usedherein would include a pressure sensor and a barometric sensor becauseboth can be used to determine flow.

As used herein, “ambient air” refers to air surrounding a medical devicesuch as an inhaler.

Detailed embodiments of the present invention are disclosed herein;however, it is to be understood that the disclosed embodiments aremerely exemplary of the invention that may be embodied in various andalternative forms. The figures are not necessarily to scale; somefeatures may be exaggerated or minimized to show details of particularcomponents. Therefore, specific structural and functional detailsdisclosed herein are not to be interpreted as limiting, but merely as arepresentative basis for teaching one skilled in the art to employvariously the present invention.

While particular embodiments of the present invention have beendescribed, it is understood that various different modifications withinthe scope and spirit of the invention are possible. The invention islimited only by the scope of the appended claims.

We claim:
 1. A respiratory device monitoring system for monitoring theuse of an inhaler, the inhaler having a hollow inhaler body that isL-shaped and which includes a mouthpiece section at a first end of theinhaler body and an opening at a second end of the inhaler body with anopening diameter that is larger than an outer diameter of a canisterthereby accepting a canister in the inhaler body, the canistercontaining an inhaler medication that is actuated by pressing a top ofthe canister to move the canister inwards into the inhaler body toprovide a medication dose, wherein the length of the inhaler body isselected such that the canister top and a length of the canisteradjoining the canister top protrude from the inhaler body opening, theinhaler body further including an internal inhaled-air passage locatedfrom the inhaler body opening and extending through the mouthpiece,wherein the inhaled-air passage is located in a space between theinhaler body and a canister mounted in the inhaler body, wherein theinhaler is configured so that both the inhaler medication and theinhaled-air passage are connected to the mouthpiece at a point ofconvergence whereby a user who inhales through the mouthpiece willinhale both the dose of medication from a canister and air through theinhaled-air passage, the monitoring system comprising: a tracking modulecomprising a flexible shell that has a shell body wrapped around theinhaler body from the mouthpiece to the inhaler body opening, theflexible shell not covering the inhaler body opening, the flexible shellhaving a tracking module processor to which are connected a trackingmodule non-transient memory, and a tracking module communicationscomponent, the flexible shell also including a tracking module battery,wherein the battery is connected to provide electrical power to theprocessor, the memory, and the communications component; wherein theflexible shell further includes a flap extending over the top of acanister that is mounted through the inhaler body opening, wherein theflap includes a dose sensor mounted in the flap at a position selectedso that the dose sensor will be in contact with the top of the canisterto sense pressure applied to the top of the canister to actuate thecanister to provide a medication dose through the mouthpiece of theinhaler, the dose sensor providing a dose signal when it has sensed saidactuation pressure, wherein the flap does not cover the opening of theinhaler body; wherein the tracking module processor is in communicationwith the dose sensor and is programmed to receive a dose signal from thedose sensor, and to store the received dose signal in the trackingmodule memory with an associated time/date stamp; wherein the flapfurther comprises an extension portion to which is mounted an air flowsensor located wherein the extension portion has a length so that theair flow sensor is located within the inhaled-air passage of the inhalerbody when the flap is mounted in contact with the top of the canister,wherein the air flow sensor detects a flow of air in the inhaled-airpassage when a user inhales through the inhaler for a medication dose,the air flow sensor providing air flow data in response to detecting airflow drawn through the inhaled-air passage when a user of the inhalerinhales; wherein the tracking module processor is in communication withthe air flow sensor and is programmed to receive the inhaled-air datafrom said sensor and to store the inhaled-air data in the non-transientmemory with an associated time/date stamp; and an application programstored in a local device that is in communication with the trackingmodule communications component of the tracking module, the applicationprogram configured to program the local device to communicate with thetracking module processor to request stored dose data with itsassociated time stamps and inhaled-air data with its associatedtime/date stamps to be transmitted to the local device, wherein theapplication program further programs the local device to receive thetransmitted dose data and inhaled-air data with their respectiveassociated time stamps.
 2. The monitoring system of claim 1 wherein theair flow sensor is located in the inhaled-air passage upstream of thepoint of convergence of the inhaler medication and the inhaled airpassage, the air flow sensor comprising a pressure sensor configured toprovide upstream pressure data to the tracking module processor forstorage in the tracking module memory with associated time/date stamps.3. The monitoring system of claim 2 wherein the application programs thelocal device to receive upstream pressure data and dose data from thetracking module; and to compare length time and pressure of the upstreampressure of the inhaled air with the time of the dose data to provideinhaler technique data based on the comparison.
 4. The monitoring systemof claim 1 wherein the air flow sensor comprises a first air flow sensorlocated in the inhaled-air passage upstream of the point of convergenceof the inhaler medication and the inhaled air passage, and a second airflow sensor located in the inhaled-air passage downstream of the pointof convergence of the inhaler medication and the inhaled air passage;wherein the first and second air flow sensors comprise first and secondpressure sensors respectively and the first pressure sensor providesupstream pressure data to the tracking module processor for storage inthe tracking module memory with associated time/date stamps, and thesecond pressure sensor provides downstream pressure data to the trackingmodule processor for storage in the tracking module memory withassociated time/date stamps.
 5. The monitoring system of claim 4 whereinthe application programs the local device to receive upstream pressuredata and downstream pressure data and dose data from the trackingmodule; and to compare lengths of time and pressure of the upstream anddownstream pressures of the inhaled air with the time of the dose datato provide inhaler technique data based on the comparison.
 6. Themonitoring system of claim 1 wherein the tracking module furthercomprises a biometric sensor configured to receive biometric data of apossible user; wherein the tracking module memory includesidentification data of the inhaler to which the tracking module ismounted; wherein the tracking module processor is further programmed toreceive biometric data from the biometric sensor, and transmit thereceived biometric data to the local device; and wherein the applicationrunning on the local device programs the local device to compare thereceived biometric data from the tracking module processor and comparethe received biometric data to authorized user data, and depending onthe comparison, indicate that the received biometric data matches anapproved user of the inhaler.
 7. The monitoring system of claim 1wherein the application program programs the local device to: receiveinhaled air data and dose data from the tracking module for a particularinhalation; process the received inhaled air data to provide flow ratedata; and compare the flow rate of the inhalation to the dose data todetermine a quality of inhalation.
 8. The monitoring system of claim 7wherein the local device includes a display; wherein the applicationprogram programs the local device to display the quality of inhalationon the display.
 9. The monitoring system of claim 1 wherein the trackingmodule further comprises an air flow control device having an orifice ofa known size, the air flow control device configured to block ambientair from flowing into the inhaled-air passage of the inhaler exceptthrough the orifice in the air flow control device; and wherein theapplication program programs the local device to determine the flow ratebased on the time of inhalation and the known size of the orifice. 10.The monitoring system of claim 9 wherein the air flow sensor comprises apressure sensor located in the inhaled-air passage upstream of theconvergence point; and wherein the local device is programmed todetermine the flow rate based on dose data, pressure data, and the knownsize of the orifice.
 11. The monitoring system of claim 1 wherein: thetracking module includes an accelerometer that provides accelerationdata, location data, and orientation of the inhaler data; wherein thetracking module further comprises a user proximity sensor that sensesthe proximity of a user to the inhaler and provides user proximity data;the application programs the local device to receive dose data, air-flowdata, environmental data, and medication use data and store saidreceived data as associated with a user's inhalation; and theapplication programs the local device to determine a quality ofinhalation based on a comparison of the dose data and air-flow data. 12.The monitoring system of claim 11 wherein: environmental data includesat least one of temperature, humidity, allergens, pollution, and airparticulates; and medication use data includes at least one of asthmatreatment pills, injector pen use, and other medication use.
 13. Themonitoring system of claim 11 wherein the local device is programmed toprovide coaching to a user to improve inhalation technique based on thequality of inhalation determined from the data comparison.
 14. Themonitoring system of claim 1 wherein the application programs the localdevice to operate in a training mode where dose data and air-flow datareceived from the tracking module are compared to provide advice to auser to change inhalation technique.
 15. The monitoring system of claim1 wherein the tracking module comprises an accelerometer fixedlyattached to the tracking module and connected with the tracking moduleprocessor, the accelerometer configured to provide data concerningshaking movement of the inhaler body to which the tracking module ismounted; and wherein the tracking module processor is programmed toreceive and store dose data and the accelerometer shaking data in thetracking module memory.
 16. The monitoring system of claim 1 wherein thetracking module further comprises a zero-power vibration sensorconnected to the tracking module processor, the vibration sensorproviding a vibration signal upon sensing vibration of the trackingmodule; and wherein the tracking module processor is programmed toremain in a low-power consumption sleep mode until a vibration signal isreceived at which time the tracking module enters an operational mode.17. The monitoring system of claim 1 wherein the tracking module and theair flow sensor attached thereto are configured to be mountedtemporarily to an inhaler and are thereby reusable with multipleinhalers.
 18. A method of monitoring the use of an inhaler, the inhalerhaving a hollow inhaler body that is L-shaped and which includes amouthpiece section at a first end of the inhaler body and an opening ata second end of the inhaler body with an opening diameter that is largerthan an outer diameter of a canister thereby accepting a canister in theinhaler body, the canister containing an inhaler medication that isactuated by pressing a top of the canister to move the canister inwardsinto the inhaler body to provide a medication dose, wherein the lengthof the inhaler body is selected such that the canister top and a lengthof the canister adjoining the canister top protrude from the inhalerbody opening, the inhaler body further including an internal inhaled-airpassage located from the inhaler body opening and extending through themouthpiece, wherein the inhaled-air passage is located in a spacebetween the inhaler body and a canister mounted in the inhaler body,wherein the inhaler is configured so that both the inhaler medicationand the inhaled-air passage are connected to the mouthpiece at a pointof convergence whereby a user who inhales through the mouthpiece willinhale both the dose of medication and air through the inhaled-airpassage, the method comprising: sensing the administration of a dose ofinhaler medication by a tracking module that comprises a flexible shellthat has a shell body wrapped around the inhaler body from themouthpiece to the inhaler body opening, the flexible shell not coveringthe inhaler body opening, the flexible shell having a tracking moduleprocessor to which are connected a tracking module non-transient memory,and a tracking module communications component, the flexible shell alsoincluding a tracking module battery, wherein the battery is connected toprovide electrical power to the processor, the memory, and thecommunications component; wherein the flexible shell further includes aflap extending over the top of a canister that is mounted through theinhaler body opening, wherein the flap includes a dose sensor mounted inthe flap at a position selected so that the dose sensor will be incontact with the top of the canister to sense pressure applied to thetop of the canister to actuate the canister to provide a medication dosethrough the mouthpiece of the inhaler, the dose sensor providing a dosesignal when it has sensed said actuation pressure, wherein the flap doesnot cover the opening of the inhaler body; receiving and storing dosesignals as dose data representative of sensed doses the sensed dose inthe tracking module memory with a date/time stamp; sensing air flowthrough the inhaled-air passage during an inhalation by the flap whichfurther comprises an extension portion to which is mounted an air flowsensor, the extension portion having a length so that the air flowsensor is located within the inhaled-air passage of the inhaler bodywhen the flap is mounted in contact with the top of the canister;wherein the air flow sensor senses a flow of air in the inhaled-airpassage when a user inhales through the inhaler for a medication doseand the air flow sensor provides air flow data in response to sensingair flow; storing in the tracking module memory the air flow data withan associated time/date stamp; and programming a local device that is incommunication with the tracking module to receive the stored dose dataand associated time stamps and air flow data and associated time/datestamps.
 19. The method of monitoring the use of an inhaler of claim 18wherein the step of programming comprises programming the local devicefor: receiving inhaled air data and dose data from the tracking modulefor a particular inhalation; processing the received inhaled air data toprovide flow rate data; and comparing the flow rate of the inhalation tothe dose data to determine a quality of inhalation.
 20. The method ofmonitoring the use of an inhaler of claim 19 wherein the local deviceincludes a display; wherein the step of programming comprisesprogramming the local device to display the quality of inhalation on thedisplay.
 21. The method of monitoring the use of an inhaler of claim 18wherein the tracking module further comprises an air flow control devicehaving an orifice of a known size, the air flow control deviceconfigured to block ambient air from flowing into the inhaled-airpassage of the inhaler except through the orifice in the air flowcontrol device; and wherein the step of programming comprisesprogramming the local device to determine the flow rate based on thetime of inhalation and the known size of the orifice.
 22. The method ofmonitoring the use of an inhaler of claim 21 wherein the air flow sensorcomprises a pressure sensor located in the inhaled-air passage upstreamof the convergence point; and wherein the step of programming comprisesprogramming the local device to determine the flow rate based on dosedata, pressure data, and the known size of the orifice.
 23. The methodof monitoring the use of an inhaler of claim 18 wherein: the trackingmodule includes an accelerometer that provides acceleration data,location data, and orientation of the inhaler data; wherein the trackingmodule further comprises a user proximity sensor that senses theproximity of a user to the inhaler and provides user proximity data; thestep of programming comprises programming the local device to receivedose data, air-flow data, environmental data, and medication use dataand store said received data as associated with a user's inhalation; andprogramming the local device to determine a quality of inhalation basedon a comparison of the dose data and air-flow data.
 24. The method ofmonitoring the use of an inhaler of claim 23 wherein: the step ofprogramming comprises programming the local device to receiveenvironmental data that includes at least one of temperature, humidity,allergens, pollution, and air particulates; and medication use data thatincludes at least one of asthma treatment pills, injector pen use, andother medication use.
 25. The method of monitoring the use of an inhalerof claim 18 wherein the tracking module comprises an accelerometerfixedly attached to the tracking module and connected with the trackingmodule processor, the accelerometer configured to provide dataconcerning shaking movement of the inhaler body to which the trackingmodule is mounted; and further comprising programming the trackingmodule processor to receive and store dose data and the accelerometershaking data in the tracking module memory.
 26. The method of monitoringthe use of an inhaler of claim 18 wherein the tracking module furthercomprises a zero-power vibration sensor connected to the tracking moduleprocessor, the vibration sensor providing a vibration signal uponsensing vibration of the tracking module; and further comprisingprogramming the tracking module processor to remain in a low-powerconsumption sleep mode until a vibration signal is received at whichtime the tracking module enters an operational mode.
 27. The method ofmonitoring the use of an inhaler of claim 18 further comprisingattaching the tracking module and the air flow sensor to the inhalertemporarily so that they are thereby reusable with multiple inhalers.